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Optimum Platelet Inhibition After Coronary Bypass Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Papworth Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00262275
First received: December 5, 2005
Last updated: January 21, 2016
Last verified: January 2016
  Purpose
To investigate the effect of different dosages of aspirin on platelet aggregation and to determine the possible mechanisms of aspirin resistance, we intend to compare the effects of low, medium dose aspirin with clopidogrel (an alternative antiplatelet agent) in patients after coronary artery bypass surgery.

Condition Intervention
Ischemic Heart Disease
Drug: Aspirin, Clopidogrel

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Optimum Platelet Inhibition After Coronary Artery Bypass Surgery: A Randomised Trial Comparing Platelet Aggregation Using Low, Medium Dose Aspirin and Clopidogrel

Resource links provided by NLM:


Further study details as provided by Papworth Hospital NHS Foundation Trust:

Study Start Date: July 2002
Primary Completion Date: July 2004 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

We intend to invite patients aged 18 to 80 proceeding to primary elective coronary artery bypass surgery, able to give informed consent.

Exclusion Criteria:

Preoperative exclusion criteria:

  • patients who are have not stopped aspirin 7 days prior to surgery
  • patients on concomitant NSAIDS
  • patients with a previous history platelet disorders, splenectomy or haematological disorders
  • patients with aspirin induced asthma
  • patients with any contraindications to aspirin (GI bleed)
  • patients who are on any medication that may result in a serious drug interaction with aspirin (warfarin)
  • Women of childbearing potential
  • Patients of less than 18 years
  • If informed consent cannot be obtained
  • If for any reason the consultant surgeon or anaesthetist deems it to be appropriate

Operative exclusion criteria:

• Concomitant procedures

Postoperative exclusion criteria:

  • patients who receive platelet transfusion
  • patients who receive NSAIDS
  • requirement for intra aortic balloon pump support
  • failure of extubation within 24 hours
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00262275

Locations
United Kingdom
Papworth Hospital
Cambridge, United Kingdom, CB3 8RE
Sponsors and Collaborators
Papworth Hospital NHS Foundation Trust
Investigators
Principal Investigator: Eric Lim, MB ChB, MSc, MRCS Papworth Hospital
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Papworth Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT00262275     History of Changes
Other Study ID Numbers: LREC 01/624 
Study First Received: December 5, 2005
Last Updated: January 21, 2016
Health Authority: United Kingdom: National Health Service

Additional relevant MeSH terms:
Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Aspirin
Clopidogrel
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on December 08, 2016